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Pain Management Health Center

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Despite Risks, Pain Relievers Given OK

FDA Panel Says Vioxx Can Come Back, Celebrex, Bextra Should Stay

Warnings for Older Pain Relievers continued...

Graham said the data suggest that researchers must take a closer look at older anti-inflammatory drugs to learn more about their possible safety concerns.

"Clearly this is going to be a complex undertaking," panelist John Jenkins, MD, said. "Not all members of this class have the same amount of data."

Panelists warned that attaching strict warnings to Cox-2 drugs while giving weaker warnings to older anti-inflammatory drugs could be dangerous if it drove patients to take traditional drugs that may also have similar risks.

"They would have the false reassurance that there's not a problem, and we don't know that there's not a problem," he said.

Naproxen, sold under many brand names including Aleve, could end up being the only anti-inflammatory exempt from warnings because of several studies that show it causes significantly fewer heart and stroke problems than do Cox-2 drugs.

FDA experts said that previous reports linking naproxen to an increase in heart attacks were unjustified and unnecessarily scared the public.

Naproxen is better for you than the other anti-inflammatory drugs right now at least in terms of heart risk, Wood said.

Weighing the Good and the Bad

Cox-2 drugs are favored by many doctors because they may be less likely to cause stomach ulcers and bleeding than older anti-inflammatory drugs.

Experts ultimately struggled with a puzzle: Is the potential benefit of fewer stomach problems worth the small but probable increased risk of heart attacks? And which patients are at the highest risk for the drugs' potentially negative effects?

Steven Nissen, MD, medical director at The Cleveland Clinic, said that decisions on whether or not to take Bextra, Celebrex, or other drugs remain "filled with shades of gray."

Wood says, "These issues are really difficult. We all wished we had more data that would inform us better." He adds that patients taking any anti-inflammatory drug should meet with their doctors to see if they are at higher risk for adverse reactions.

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